The FDA has accepted Sunovion’s NDA for SUN-101 glycopyrrolate delivered by the PARI eFlow nebulizer for the treatment of COPD, the company said. The agency has set a PDUFA date of May 29, 2017 for completion of its review of the application.
In April 2016, Sunovion announced that the GOLDEN-3 and GOLDEN-4 trials of SUN-101 had met their primary endpoints and said at the time that it planned to submit an NDA by the end of 2016. In July 2016, the company announced positive results from the GOLDEN-5 long term safety study and then submitted the NDA the following week.
Sunovion Executive VP and Chief Medical Officer and Head of Global Clinical Development for Sumitomo Dainippon Pharma Group Antony Loebel commented, “SUN-101/eFlow demonstrates Sunovion’s commitment to delivering innovative therapies for patients with COPD. If approved, SUN-101/eFlow would be the first nebulized LAMA for patients with COPD. We look forward to working with the FDA as we seek to gain approval of this innovative drug-device combination and further address the needs of patients with this debilitating condition.”
Read the Sunovion press release.
